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• Nuclear Medicine modalities can reveal changes earlier than pure anatomical imaging
• But there is no image without tracer
• FDG is a partially approved tracer in PET, showing good correlation with survival in some disease areas. Conventional NM also offers approved tracers for diagnostic purposes.
• But the true power of Molecular Imaging goes beyond approved imaging agents
• Impact of different production techniques - difficult to assess
• Standardized production is appreciated - but not always possible across all centres, due to different technologies available.
• But standardized quality control of product and pre-defined criteria for acceptance are feasible for all.
Beyond standardizing scanning equipment it is also important to standardize production and quality control especially of new non-approved radiopharmaceuticals
• In his famous speech at the University of Zurich on 19 September 1946, Sir Winston Churchill called for a United States of Europe and the creation of a Council of Europe (founded 1949).
• It has a particular emphasis on legal standards, human rights, democratic development, the rule of law and cultural co-operation. It has 47 member states.
– European Court of Human Rights– European Pharmacopoeia Commission
• The European Medicines Agency is the EU body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
• The Agency provides the Member States and the institutions of the EU the best-possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products.
• Genuinely novel medicines are authorized through the EMEA
• The scientific assessment is decentralized and EMEA draws on resources of National Competent Authorities (NCAs) of EU Member states.
• The CHMP (Committee for Medicinal Products for Human Use) is obliged by the Regulation to reach decisions within 210 days, but the clock is stopped if clarification/more information is needed.
• Within the EU EMEA as agency and EudraLex as collection of rules and regulations offer a vague framework for use of radiopharmaceutical products in clinical trials.
• The NCAs & ethics committees, are responsible, in each Member State, for the oversight of clinical trials and their conduct.
• They authorize manufacturing sites in their territories.
• Active pharmaceutical ingredient starting material [In a radionuclide generator, both mother and daughter radionuclides are to be considered as active ingredients!]
• Finished drug [short half-life – not all QC tests needed prior to application]
• Minimal range of tocoxological data [depends if within limits of microdosing or not -> SA]
• Dosimetry data
Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU, EJNM 2008 Nov;35(11):2144-51
„Strategies for Clinical Implementation and Quality Management of PET Tracers” International Atomic Energy Agency Vienna, 2009
“…encourage further cooperation among various countries worldwide in the development of a set of harmonized acceptance test criteria for PET systems and sensible QA standards for all PET drug products. ...”
EANM: Draft Guidelines for Radiopharmacy [Eur J Nucl Med Mol Imag (2003) 30:BP63–BP72]:
The Committee has adopted the strategy of starting to develop “Draft guidelines for radiopharmacy” for nuclear medicine laboratories and to adapt the “Preliminary draft regulations on current good manufacturing practices for PET drugs” of the U.S. Food and Drug Administration
• Distribution within Europe and across EU and non-EU borders needs special attention
• Distribution distances and customs procedures are vital for the success and feasibility of a clinical multi-center trial.
• Production site needs to submit it‘s monograph also to Health Authorities of receiving Institutes. Additional quality control might be needed on site.